FDA

FDA approves crofelemer as first-ever oral botanical 'drug'

Monday, January 21, 2013 by: Ethan A. Huff, staff writer
Tags: crofelemer, plant drugs, FDA approval

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(NaturalNews) For the first time in its history, the U.S. Food and Drug Administration (FDA) has approved an orally-administered herbal botanical for use as a treatment in medicine. According to the American Botanical Council (ABC), the botanical, known as crofelemer, is derived from a South American tree known as "sangre de dragon," or "dragon's blood" in English, and has been approved for use in the treatment of HIV-associated diarrhea.

The decision marks the second time ever that the federal agency has approved a botanical for the treatment of disease, with the first-ever approval having been granted in 2006 for a topical green tea extract marketed as Veregen (sinecatechins). According to an FDA press release, crofelemer, which will be sold under the trade name Fulyzaq, meets all the requirements for recognition as an American pharmaceutical, and will be dispensed only by prescription.

"The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy (ART) with a history of diarrhea lasting one month or longer," says the release. "Results showed that 17.6 percent of patients taking Fulyzaq experienced clinical response compared with eight percent taking placebo. In some patients, a persistent anti-diarrheal effect was seen for 20 weeks."

According to Fulyzaq's label, the so-called "drug" blocks the secretion of chloride ions by intestinal epithelial cells, which helps normalize the flow of chloride ions and water throughout the gastrointestinal tract. In essence, the substance helps reduce the excess water produced in the gut as a result of taking antiretroviral drugs for HIV infection. Fulyzaq may also be effective in treating acute infectious diarrhea and the diarrhea associated with irritable bowel syndrome (IBS).

FDA-approved botanicals no longer available on free market

Many are lauding this landmark move by the FDA as a positive step forward in the advancement of natural medicine. But one of the major problems with reclassifying natural botanicals as "drugs" is that, once approved, these substances may no longer be freely available as nonproprietary nutrients. In other words, what was once considered to be the property of nobody is now a patented medicine owned by a private corporation with a vested interest in maintaining a strict monopoly on it.

In the case of crofelemer, its active ingredient is essentially the sap of the Amazonian Croton lechleri tree, which apparently has strong therapeutic value in the treatment of diarrhea. This sap, which is commonly sold as a nutritional supplement, is now at risk of becoming the intellectual property of Napo Pharmaceuticals, the company that owns the intellectual property rights of the drug.

So while the FDA's approval of crofelemer represents what appears to be a positive change in the agency's attitude towards natural products, it is also ominous of a future in which many more natural products become licensed "drugs" owned by private companies rather than nature itself. And as a community unified in protecting access to natural substances, we must all be vigilant to guard nature from greedy opportunists that would try to steal it for private gain.

Sources for this article include:

http://cms.herbalgram.org/press/2013/FDA_Approves_Crofelemer.html

http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3840

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